Most Phase IV studies use interventional-grade EDC systems designed for highly controlled Phase II-III trials. This creates unnecessary complexity, inflated costs, and extended timelines for studies that require observational flexibility, not interventional constraints.
Generate Real-World Evidence at Real-World Speed
Launch Phase IV trials in weeks, not quarters. Purpose-built infrastructure for post-marketing studies that need to move quickly, integrate seamlessly, and deliver high-quality RWE without interventional trial overhead.
Why Most Registries Struggle to Scale
Patient registries generate invaluable longitudinal data. Yet traditional infrastructure makes them expensive to launch, difficult to sustain, and nearly impossible to scale affordably.
Commercial launches don't wait for Phase IV infrastructure. Every month spent configuring systems and activating sites delays evidence generation during critical post-approval periods when market access and formulary decisions are being made.
Phase IV studies operate in diverse clinical settings with varying capabilities, competing with routine care demands. Traditional systems require extensive site training and dedicated research coordinators that many real-world sites cannot provide.
Post-marketing studies need to leverage existing healthcare data and workflows. Legacy systems operate as isolated platforms, requiring duplicate data entry and creating friction between research activities and clinical care.
Purpose-Built Infrastructure for Observational Research
Carelane delivers observational study capabilities optimised for Phase IV requirements: rapid deployment, real-world pragmatism, and seamless integration with existing healthcare infrastructure.
Digital Protocols Integrated with Routine Care
Deploy FHIR-based digital protocols that integrate directly with clinical workflows. Rather than creating parallel research systems, Carelane aligns study activities with routine care, reducing site burden by 50-85% and improving protocol compliance.
Rapid Multi-Site Deployment
Launch Phase IV programs with unprecedented speed. Activate up to 60 sites in a single week across multiple countries, complete with capability assessment and onboarding. Reduce site selection time through intelligent feasibility workflows, ensuring your evidence generation stays ahead of commercial timelines.
FHIR Interoperability and Standards-Based Data Exchange
Seamlessly integrate with existing healthcare IT infrastructure using FHIR standards and clinical terminologies (ICD-10, SNOMED, LOINC). Eliminate duplicate data entry, leverage existing EHR data, and enable automated data flows that reduce manual effort by 70-95% while maintaining data quality and regulatory compliance.
Pragmatic Trial Design Support
Optimise for real-world evidence generation with flexible enrolment criteria, minimal exclusions, and adaptive data collection. Reduce EDC setup time by 70-90% through libraries of eCRFs and automated configuration tools designed specifically for observational research requirements.
Proven Performance Across Post-Marketing Programs
CROs and pharmaceutical sponsors are leveraging Carelane to accelerate Phase IV execution, reduce operational costs, and deliver regulatory-grade RWE faster.
Launch
in Days
Complete Phase IV deployment from protocol finalization to first patient enrollment, measured in weeks not quarters
Up to 60 Sites
in 1 Week
Multi-country site activation including capability assessment, feasibility review, and complete onboarding
70-90%
Setup Time Reduction
Automated EDC configuration and protocol digitization eliminate months of manual work
50-85%
Site Burden Reduction
Direct data capture from EHRs and patient-reported outcomes minimize manual data entry and coordinator workload
80%+
Operational Automation
Near-complete automation of routine tasks including adherence monitoring, IP accountability, and documentation, allowing teams to focus on strategic oversight
Value Proposition
For CROs
Scale your observational research offering with efficient, high-margin Phase IV capabilities. Deliver superior quality to sponsors while reducing operational overhead. Win more business by demonstrating faster timelines and lower costs without compromising data quality.
For Pharmaceutical Sponsors:
Execute Phase IV studies in-house with small teams. Maintain control over evidence generation strategy while eliminating vendor dependencies and markup. Deploy studies during critical post-launch windows when RWE directly impacts market access decisions.
Real-World Evidence is Redefining Drug Development
Regulatory bodies, payers, and healthcare systems increasingly rely on post-marketing evidence for coverage and formulary decisions. Speed to quality RWE generation directly impacts commercial success.
Regulatory Evolution
FDA, EMA and international regulators now accept real-world evidence for label expansions, safety updates, and comparative effectiveness claims. Phase IV studies can generate evidence that directly enhances product value—if executed quickly enough to matter.
Competitive Differentiator
In crowded therapeutic areas, high-quality RWE distinguishes products from competitors. Organisations that generate Phase IV evidence faster gain strategic advantages in market positioning and clinical guideline influence.
Operational Efficiency
Phase IV budgets face increasing scrutiny. Studies using interventional-grade infrastructure for observational research waste resources on unnecessary complexity. Purpose-built observational tools enable better quality at lower costs.
Ready to try Carelane?
The only end-to end solution for observational trials.
Unlock research at scale, slashing costs, complexity and friction!
